Medical Prognosis Institute A/S announced today that Oncology Venture, the drug development arm of MPI, and Lantern Pharma, Inc. (Dallas, TX, US) have entered into a definitive agreement and partnership to clinically advance Irofulven for the treatment of metastatic castration resistant prostrate cancer (mCRPC) by utilizing a highly predictive biomarker for the drug developed by MPI.
The agreement follows on the companies' receipt, in March 2015, of an USD 800,000 grant under the Life Sciences International Collaborative Industry Program (ICIP), administered by the Massachusetts Life Sciences Center (MLSC) and its Danish funding equivalent, the Region Hovedstaden. Under the partnership, OV will have exclusive, worldwide rights to clinically develop and commercialize Irofulven in the cancer field. Lantern will receive certain license fees, milestone payments, and royalties, and OV will receive shares of Lantern. Further financial details of the agreement were not disclosed. Clinical trials are anticipated to occur in Boston, MA and/or Copenhagen, Denmark.
MPI has developed a highly validated, systems-biology-based biomarker platform, the Drug Response Predictor (DRP(TM)), which is useful for identifying likely responding patients for targeted enrollment of cancer drug clinical trials. Oncology Venture acquires and invests in promising cancer drugs that have previously failed clinical efficacy trials, but which can be repurposed for the right indication and right patients utilizing MPI's DRP(TM) Biomarkers. Lantern holds the rights to Irofulven. Irofulven, a transcription-coupled repair specific antitumor agent, has shown promise in a number of prior clinical trials but has not reached suitable efficacy endpoints. Under the partnership, and utilizing the ICIP grant funding, OV and Lantern will employ an Irofulven-specific DRP(TM) biomarker developed by MPI to select and enroll likely responder patients in a targeted Phase 2 trial for the drug in mCRPC (also known as HRMPC). mCRPC is the leading cause of mortality among prostate cancer patients.
"We are thrilled to partner with Lantern in order to advance the clinical development of Irofulven, and to advance a new paradigm in cancer drug development by designing and conducting clinical trials around a targeted population of patients identified, via MPI's diagnostic platform, as the patients most likely to respond to a given drug based on their tumor biology." Said Professor Peter Buhl Jensen, M.D., CEO of Oncology Venture and MPI. "The creation of our partnership with Lantern, on the heels of our ICIP grant award, further underscores the promise of our novel approach to treating the right patients with the right drug," said Buhl Jensen.
Dr. Arunkumar Asaithambi, Ph.D., Co-founder of Lantern Pharma, further commented: "We are excited about our Irofulven partnership with Oncology Venture, which emphasizes Lantern's commitment to the development of precision cancer drugs by employing cutting-edge companion diagnostics, i.e. MPI's DRP(TM) Biomarker, to identify and enroll the right cancer patients in order to conduct successful clinical trials with patients that will actually benefit from Irofulven."
"We are highly enthusiastic about working with Lantern on this drug repurposing project, and are confident that our DRP(TM) Biomarker for Irofulven will enable the identification and selection of likely responder patients for the targeted-enrollment Phase II trial in mCRPC," noted Dr. Steen Knudsen, Ph.D., CSO and Founder of MPI.
About Oncology Venture
Oncology Venture A/S, a spinout from MPI, is focusing on finding and develop failed cancer drugs by conducting new, targeted-enrollment clinical trials utilizing highly predictive DRP(TM) Biomarkers to select, enroll, and treat the right patients and right cancers.
Medical Prognosis Institute, Inc. advances personalized medicine by partnering with cancer drug developers to apply its DRP(TM) diagnostic platform to streamline and de-risk clinical trials and drug development via biomarker optimization, patient stratification, and development of companion diagnostics.
About Lantern Pharma
Lantern Pharma is advancing precision cancer medicine by combining clinical stage chemotherapeutics with personalized genetic testing to de-risk clinical development. Lantern holds the rights to Irofulven.
About MPI's multiple biomarker called Drug Response Predictor - DRP(TM)
MPI's lead product, the DRP(TM) diagnostic platform, is a tool to develop tumor-derived gene signatures that may predict which cancer patients are highly likely responders to a given anticancer product. The DRP(TM) has been tested in 26 trials, where 22 trials showed that drug-specific DRP(TM) Biomarkers could predict which patients had a positive effect of the treatment. The DRP(TM) platform has also been externally validated and published in collaboration with leading statisticians at the MD Anderson Cancer Center. The DRP(TM) method can be used to design the Clinical Development Plan, i.e. to select which indications are relevant for a given anticancer drug. Further to and in addition to this, individual patients' gene patterns can be analyzed as part of a screening procedure for a clinical trial to ensure inclusion of those patients who have a high likelihood of response to the drug. The DRP(TM) platform can be used in all cancer types and has been patented for more than 60 anticancer drugs in the US.
For further information please contact
CEO Peter Buhl Jensen, Professor, MD, PhD
Cell Phone: (+45) 21 60 89 22
James G. Cullem, J.D.
VP of Corporate Development
Cell Phone: +1 (978) 500-0863
Certified Advisor: Carsten Yde Hemme, PricewaterhouseCoopers, Strandvejen 44, 2900 Hellerup, Denmark